Patrick Hensley: Hi, Ashish. Thanks so much for having me. Without further ado, I'll go through some things that I'm really looking forward to in DC this year. To get started, we'll see some really exciting trial readouts. This first presentation will be by yourself looking at the intravesical novel agent EG70 or detalimogene. This is a novel non-integrating non-viral therapy that induces an inflammatory response in the bladder, both with innate immunity and adaptive immunity through some transgene expression driving expression of RIG-I agonists as well as IL-12 expression. This is being studied in a phase-two trial. We saw some early results from the incompletely enrolled cohort one presented at GU ASCO in 2025 and they presented a CR at any time of 71% in the BCG-unresponsive cohort. You can see we are blessed with a number of new treatments in the BCG-unresponsive space with lots of novel mechanisms of action.
So we're really excited to see how the detalimogene story plays out. In the Friday plenary, we're also seeing some updates from the POTOMAC study that'll be presented by Neal Shore. As you know, there were recently three trials that were reported looking at the combination of BCG plus systemic immunotherapy in the BCG-naive setting. CREST and POTOMAC demonstrated modest but statistically significant improvements in event-free survival. So there were positive studies. This is work that was recently published by the International Bladder Cancer Group and you can see that reconstruction of individual patient data from the Kaplan-Meier analysis from these three, phase-three trials combining BCG plus IO show that the absolute clinical benefit of adding systemic therapy appears modest at best when examined across these studies. We hypothesize that if any patient were to benefit from this therapeutic escalation using systemic therapy, it'd be the highest risk patients.
And that's exactly what Dr. Pietzak will present in his IET. This is a phase-two trial combining pembrolizumab with BCG for highest risk, high-grade T1 non-muscle-invasive bladder cancer. Lastly, on Friday, Dr. Jeremy Teoh will deliver the John Lattimer lecture presenting a novel en-bloc transurethral resection technique using a robotic surgery platform. As you know, Jeremy has really been a pioneer of en-bloc resection and quality TUR in general and he has spearheaded the most quality evidence that we have thus far for en-bloc resection in this phase-three trial of 350 patients. So we're really looking forward to his insights in this lectureship. The Society of Basic Urologic Research and the Society of Urologic Oncology have a joint session on Saturday as they always do. And this will highlight a number of plenary discussions and I'm particularly looking forward to Dr. Alan Tan's discussion on minimal residual disease in the urothelial cancer space with improved ctDNA and compelling data emerging for urine tumor DNA.
We're kind of in this uncharted era after definitive therapy as these minimal residual disease classifications are now enabling us for better patient risk stratification, prognostication, and even treatment de-intensification in the perioperative sandwich therapy era. Lastly, my annual AUA highlight and probably yours as well is the annual AUA International Bladder Cancer Group Forum hosted by yourself and this year, Dr. Sarah Psutka from the University of Washington. This is a highly interactive rapid-fire debate style session with some built-in audience response systems. And just to briefly cover some of the topics that we'll be debating this year, there'll be a session on radiation therapy focused on toxicity from tri-modality therapy in terms of management and patient selection and counseling on the risks and benefits. There'll be a BCG-unresponsive debate on first-line therapy, is gemcitabine and docetaxel, the de facto standard of care, or is it a dealer's choice novel intravesical agent?
In terms of intermediate-risk non-muscle-invasive bladder cancer, we'll be debating ablation versus transurethral resection. We will also have a discussion on the use of MRI with VIRAD scale for bladder cancer, primary tumor staging, and whether or not that's the emerging new standard of care or just an adjunct to the traditional staging paradigms. We'll discuss systemic therapy and muscle-invasive bladder cancer and whether we should be using this unrisk-stratified perioperative sandwich therapy where patients get neoadjuvant followed by adjuvant therapy regardless of their pathologic response or should we be implementing some sort of risk-adapted approach. And then we'll end the discussion on some emerging and historical biomarkers. To conclude the AUA IBCG session, each year we have adopted this group walk in solidarity for our BCAN colleagues and also patients globally, and I'm just really looking forward to this interactive time with our colleagues.
Ashish Kamat: Pat, that was a really nice summary of what to expect at AUA, and thanks for making a plug for the walk because I think it's really important the IBCG AUA forum that we're fortunate enough to host at the AUA clearly tackles important topics that are relevant to patient care. People can implement that when they go back to their office on Monday or Tuesday, but it's all about the patients and just doing that little walk and the picture is really important. So thanks for that shout out. It's funny, last two, three years we've been spoiled almost at every AUA, ASCO GU, ASCO, EAU, ESMO, there have been some groundbreaking trials, phase three studies being presented. This year really, other than the couple that you mentioned at AUA, there's not going to be any groundbreaking new trials being reported out. It's going to be more subset analyses, extensions of data sets, posters, IITs, stuff like that.
But that's important too, because again, we can't always have phase three studies. So if you look at the context of what we're going to se at AUA, are you planning to be at every poster session? Have you mapped out what you're going to do? Any tips on those that are attending AUA maybe for the first time as to how they should strategize their bladder cancer exposure?
Patrick Hensley: Well, I think the AUA does a really good job of stratifying disease states throughout the day, multiple days throughout the meeting. So there's not a whole lot of hot topic bladder cancer podiums or plenaries or poster sessions that are going concurrently. I certainly would check out the plenary sessions. I would certainly recommend that prospective folks plan ahead, look at the calendar ahead of time and just really pick out what disease states and what kind of topics are appealing to them. As you mentioned, there's not a lot of big fundamental practice-changing trial readouts, but we have so much data just to digest from these recent readouts. And I'm really looking forward to some of the subgroup analysis and the biomarker stratifications in these trials, because I think that that's just as practice-changing as the therapeutics themselves.
Ashish Kamat: Yeah, I think Dave Penson's done a really good job with trying to get the schedule in such a way that people can actually attend what they're truly interested in, but it still is just so many sessions ongoing that you really have to plan for it. One of the things that I'm really interested in your thoughts about is the clinical trials in progress. I didn't see where you mentioned that as something that you are interested in. Is it because you're not interested or is it because it's just so much going on that that was not on your priority list?
Patrick Hensley: Not at all. Along with novel treatments that we're seeing that are being FDA approved, we are seeing novel trial designs and that's really where you go as a young investigator interested in clinical trial involvement to learn how trials are rationalized and constructed. And that session in particular is not a lot of early data as much as it is just thought-provoking clinical trial designs and the future of clinical trial designs and bladder cancer. So very much looking forward to that session as well.
Ashish Kamat: Great. There's so much that's going to be happening at AUA. We are looking forward to everybody attending every session, but really, as you said, I think planning ahead, attending clearly the sessions that you mentioned and looking forward to seeing everyone there. Thanks, Pat.
Patrick Hensley: Thank you.